FDA.reportPublic FDA data

Application 078692

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET, CHEWABLE;ORAL5MGNoNo
002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET, CHEWABLE;ORAL10MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-5283Cetirizine HydrochlorideCetirizine HydrochlorideSandoz IncANDACurrent
0781-5283Cetirizine HydrochlorideCetirizine HydrochlorideSandoz IncANDACurrent
0781-5284Cetirizine HydrochlorideCetirizine HydrochlorideSandoz IncANDACurrent
0781-5284Cetirizine HydrochlorideCetirizine HydrochlorideSandoz IncANDACurrent
0904-5879Cetirizine HydrochlorideCetirizine HydrochlorideMajor PharmaceuticalsANDACurrent
11822-0578Childrens Allergy ReliefCetirizine HClRite Aid CorporationANDACurrent
49035-578Childrens Allergy ReliefCetirizine HClWal-Mart Stores IncANDACurrent
50844-578Childrens Allergy ReliefCetirizine HClL.N.K. International, Inc.ANDACurrent
50844-578Childrens Allergy ReliefCetirizine HClL.N.K. International, Inc.ANDACurrent
50844-578Childrens Allergy ReliefCetirizine HClL.N.K. International, Inc.ANDACurrent
59779-978Allergy ReliefCetirizine HClCVS PharmacyANDACurrent